October 19, 2012
ABA Litigation Section Conference on Current Issues on Pharmaceutical and Medical Device Litigation
October 20, 2009
Fall 2009 Newsletter for ABA Mass Torts Litigation Committee
The newsletter is now available and includes articles on Lone Pine orders, public nuisance law, federal preemption, sophisticated user and sophisticated intermediary defenses, the Fake Bad Scale Test, and document review.
July 22, 2009
The Advance and Retreat of Pre-emption
Was going through some old issues of the ABA Journal and found this interesting article from the May issue -- Business Downturn: As the market tumbles, so does the corporate pre-emption defense, by David G. Savage. Here's an excerpt:
For much of the decade, business lawyers and the Bush administration insisted state liability laws and state regulation amounted to a costly nuisance and a drag on the economy. They said uniform national regulation of business made more sense, and they urged the Supreme Court to limit lawsuits and to pre-empt state regulations.
For years those arguments were winners. Last year, Riegel v. Medtronic barred most lawsuits against the makers of medical devices. Lawyers for the Bush administration and device makers said state jurors should not be permitted to second-guess Food and Drug Administration regulators once they have approved a device as safe and effective.
July 20, 2009
Plaintiffs' Expert Testimony on General Causation Excluded in Non-Fusarium Eye-Infection Contact-Lens Case Against Bausch & Lomb
Article in AmLaw Litigation Daily -- Shook Hardy Wins Junk Science Dismissal for Bausch & Lomb, by Ben Hallman. Here's an excerpt:
And here's a link to the opinion by Justice Kornreich of the New York Supreme Court, New York County.
July 05, 2009
Robert Rabin on Conflicting Conceptions of Tort Preemption
Professor Robert Rabin (Stanford) has posted on SSRN his article, Territorial Claims in the Domain of Accident Law: Conflicting Conceptions of Tort Preemption, Brook. L. Rev. (forthcoming 2009). Here's the abstract:
In this article, I begin by revisiting Cipollone to reassess what it has to offer as a foundation for setting the boundaries of regulatory containment of the tort system. Next, I discuss three leading cases from the series of efforts by the Supreme Court to grapple with express preemption clauses in a variety of regulatory schemes. Against this backdrop, I then explore the circumstances under which it might be justified to imply preemption despite the absence of an express provision, with particular reference to the recent Supreme Court decision in Wyeth v. Levine, addressing preemption in the context of FDA regulation of prescription drugs. A concluding note ties the strands together.
June 08, 2009
NIH Study Questions Benefits of Stents and Diabetes Drugs Avandia and Actos
Article in the Wall Street Journal -- Diabetes Study Questions Expensive Treatments: NIH Finds Patients With Heart Disease Fare Equally Well Without Stents and Drugs Such as Avandia, Actos, by Keith J. Winstein. Here's an excerpt:
The study, sponsored by the National Institutes of Health and several drugmakers, is the latest to humble fancy new treatments by finding them no better than older medicines at preventing the deadly consequences of major diseases. The results add to a debate about alleged overuse of stents, made by companies including Abbott Laboratories, Boston Scientific Corp. and Johnson & Johnson, and controversial diabetes drugs from GlaxoSmithKline PLC and Takeda Pharmaceutical Co.
March 14, 2009
13 Deaths Tied to Medtronic Heart Device
Despite reports circulating as early as 2004 about problems with the Sprint Fidelis cable, Medtronic's medical device is still in widespread use. Barry Meier of the New York Times reports that along with roughly 13 fatalities, the FDA has received reports of 2,200 reports of serious injuries. Here's an excerpt of the article:
Separately, a previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing. The company also revised its manufacturing process in the months before withdrawing the Sprint Fidelis from the market, according to the F.D.A. report, which was provided to The New York Times by lawyers suing Medtronic.
A top Medtronic official said in an interview on Friday that the manufacturing change in question was unrelated to the reasons for the recall and that even at the time of the recall internal data did not suggest it was fracturing at a significantly higher rate than other company leads.
When Medtronic may have known the Sprint Fidelis posed safety problems, and how it responded to that information, could be significant factors if patient lawsuits over the product were to start moving forward again. This month, top Democratic lawmakers introduced legislation that would effectively nullify a Supreme Court decision last year that has blocked lawsuits against medical device makers like Medtronic. The company recently said that about 2,000 legal claims involving the Sprint Fidelis had been filed against it.
The death statistics Medtronic released Friday underscore both the scope of the Sprint Fidelis problem and the difficult choices that doctors and patients face in deciding what to do about it. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies.
March 06, 2009
Medical Device Safety Act of 2009
After the Supreme Court rejected Wyeth's preemption claim in Wyeth v. Levine, Congress took steps to reverse the Supreme Court's earlier preemption decision, Riegel v. Medtronic, Inc. House representatives Frank Pallone, Jr. (D-NJ) and Henry Waxman (D-CA) introduced the Medical Device Safety Act of 2009 to "protect patients from dangerous and defective devises by correcting the Court's flawed interpretation of the MDA." In effect, the Act restores state product liability lawsuits and restores the private attorney general's role in bringing suit. NYU recently held a symposium on the broader idea of Tort Law in the Shadow of Preemption. The symposia should be forthcoming in the NYU Annual Survey of American Law.
January 26, 2009
Pfizer to acquire Wyeth
The deal not only create a pharmaceutical behemoth but would be a rarity in the current financial tumult: a big acquisition that is not a desperate merger of two banks orchestrated by the government. It will also be the first big merger backed by Wall Street in months. While credit has been notoriously tight of late, five banks have agreed to lend Pfizer $22.5 billion to pay for the deal. Pfizer, which has roughly $26 billion in cash, would finance the remainder through a combination of cash and stock.
Every major pharmaceutical company has experienced mass tort litigation, and these two are no exceptions. Pfizer defended the Celebrex and Bextra litigation, and earlier the Bjork-Shiley heart valve litigation. Wyeth (formerly American Home Products) took a huge hit in the fen-phen litigation, and more recently has faced mass litigation over its Prempro and Premarin hormone replacement therapy products.
Last May, Amy Schulman joined Pfizer as its general counsel. Before going in-house at Pfizer, Schulman headed the mass tort practice at DLA/Piper and was lead counsel for Pfizer in the Celebrex-Bextra litigation. In December, Pfizer hired Bradley Lerman as its litigation chief. As a partner at Winston & Strawn, Lerman defended McDonald's in the fast food litigation and worked for Phillip Morris in the Engle tobacco class action.
January 24, 2009
Ethics Rules May be Tightened for Drug and Medical Device Makers
The Physician Payments Sunshine Act, a bill introduced in the Senate, is a parallel effort to that in the House to require drug and device makers to report all financial links with doctors on a federal website. Here's an excerpt from the N.Y. Times piece:
“The public is clamoring for transparency,” one of the Senate sponsors, Herb Kohl, a Wisconsin Democrat, said. The co-sponsor is Charles E. Grassley, Republican of Iowa.
The nation’s biggest hip and knee makers, including Smith & Nephew, Zimmer Holdings, DePuy and Biomet, are operating under Justice Department oversight as part of a deal to resolve allegations they gave doctors illegal inducements to use their products.
Other sectors of the device industry face continuing federal inquiries or are voluntarily taking house-cleaning measures. Much of it involves the public disclosure of information that would be mandated under the Senate proposal — the names of the doctors who work for device manufacturers as consultants, lecturers, researchers or trainers, and how much each one is paid for those services.
Under their Justice Department settlements, the hip and knee makers are already disclosing such payments on their corporate Web sites. And seeing the writing on the wall, several other large device companies, including Boston Scientific and Edwards Lifesciences, recently announced they would do so voluntarily.
Meanwhile, the device industry’s main trade group, the Advanced Medical Technology Association, said it had supported the Senate measure when it was introduced two years ago.
There is little question that battles over how much companies, doctors and medical institutions disclose about their financial ties will continue. But some experts on medical conflicts of interest, seeing the rapid fall of resistance by most major companies, say that a turning point has arrived.
October 30, 2008
Drug and Medical Device Litigation Conference
American Conference Institute is running its 13th Annual Drug and Medical Device Litigation Conference in New York on Dec. 9-11, 2008. Speakers include many of the leading defense lawyers in pharmaceutical and medical device product liability litigation, as well as a line-up of judges who have handled many of the recent cases. Topics include preemption, juror perceptions, learned intermediary, litigation holds, scientific experts, politics, global trends, and generics. Ted Mayer and I will speak on ethical considerations in mass tort settlements.
September 04, 2008
"Infuse Bone Graft" Linked to Life-Threatening Complications
The FDA has received 38 reports that Medtronic Inc.'s "Infuse Bone Graft," typically used to encourage bone growth in spinal surgeries, causes neck and throat swelling--life threatening injuries. The Wall Street Journal has a lengthy article by David Armstrong and Thomas Burton on the topic and the related lawsuits. Here's an excerpt:
Doctors with financial relationships with Medtronic have written favorably about off-label uses of Infuse on Web sites, in medical journals and at educational meetings. Some of the most influential spine surgeons in the country are consultants to the company. Several of them benefit from sales of the product through royalty deals, according to disclosures they have made in professional journals and at medical meetings.
Three "whistleblower" lawsuits brought by former employees have alleged illegal marketing, seeking refunds for the federal government on Medicare and Medicaid payments to the company. The former employees, who share in any recovery under federal law, asserted in the suits that the company paid inducements to doctors to use Infuse and other Medtronic spine products. Medtronic agreed to pay $40 million to settle two of the cases, which were filed in federal district court in Memphis, Tenn., without admitting wrongdoing. One of the whistleblowers has challenged the company's agreement with the federal government, saying the sum is too small.
The lawsuit that hasn't been settled was filed last year in federal district court in Boston by two former Medtronic employees. It alleges that the company illegally marketed Infuse for off-label purposes through doctors who were paid inflated consulting fees and bogus royalty payments. Marketing off-label uses is not allowed under FDA regulations.
July 16, 2008
Increase in Use of Drug-Coated Stents, Despite Past Safety Concerns
Article in the Wall Street Journal -- Use of Coated Stents on the Rise, by Keith J. Winstein. Here's an excerpt:
Drug-coated heart stents, whose U.S. sales were hard hit over safety concerns in the past two years, appear to be mounting a comeback.
In June, 73% of stent procedures in the U.S. used a coated stent, according to the Goodroe Data Warehouse unit of VHA Inc., of Irving, Texas, based on a survey of 60 U.S. hospitals. That is up from 62% in December -- which was the lowest level in several years -- and puts coated stents' popularity at levels not seen since February 2007, when a scientific firestorm raged over the devices' safety.
Coronary stents are tiny scaffolds that relieve chest pains by propping open clogged arteries that feed the heart. About a million Americans a year receive stents. The fanciest models are coated with drugs that prevent scar tissue from reclogging an artery and cost about $2,000, making them far more profitable than uncoated, bare-metal stents, which sell for less than half the price.
June 16, 2008
After preemption, where do mass tort lawyers go?
For mass tort plaintiffs' lawyers, the scariest legal issue of the moment is preemption. If FDA approval of a warning or product preempts state law tort claims, lots of otherwise viable mass torts disappear. Preemption has figured prominently on this blog in recent months, including here (on the Third Circuit Colacicco decision), here (on the Supreme Court split in Warner-Lambert), and here (on the Supreme Court decision in Riegel).
Plaintiff lawyers' preemption dread picks up on a running theme: tort reform as a supposed death knell for mass tort litigation. A year and a half ago, Byron Stier commented on Alison Frankel's American Lawyer piece declaring the end of the wild west era of mass tort litigation. Two months ago, we linked to a Houston Chronicle interview with a legal recruiter suggesting dim prospects for mass torts in the wake of tort reform. But mass litigators are nothing if not enterprising and resilient. To me the interesting question is not "Will mass litigation dry up?" but rather "If pharmaceutical mass torts and medical devices litigation dry up because of preemption, what's the mass litigator's next move?"
Earlier this month, Forbes.com ran a piece by William Barrett called Looking for Mass Torts. Reporting on the latest Mass Torts Made Perfect plaintiffs' attorneys conference in Las Vegas, Barrett describes the gathering's potent mix of doomsdayism and entrepreneurial verve:
But behind this bravado the lawyers are running scared. After decades of victories in asbestos and tobacco, they are contending with appeals courts rulings reining in class actions involving drugmakers. A case now before the Supreme Court could sharply curtail their bread-and-butter tort suits. The defendants are asking the court to decree that suits built on the theory that drug labels had inadequate warnings are preempted by Food & Drug Administration regulation of labels.
"These are scary times," said R. Larry Morris, another partner in the law firm of Levin Papantonio Thomas Mitchell Echsner & Proctor. Philadelphia lawyer Fred S. Longer made a presentation entitled "fda Preemption: Is This the End?"
But good businesspeople that they are, these legal practitioners are hedging their bets by seeking new markets. One possible new territory where preemption is not a big problem is litigation over environmental debacles. (Witness the recent extraction of money from gasoline refiners who damaged groundwater with a federally approved additive.) The tort mavens also talked about switching to securities law, a field not especially starving for practitioners.
The prospect of mass litigators turning from one type of litigation to another as legal developments alter their cost-benefit analysis is a theme I explore in a forthcoming article on the impact of CAFA. CAFA altered forum-selection strategy directly and indirectly in interesting ways, but beyond that, it appears to have had an impact on claim selection and litigation emphasis as well. Preemption could affect the work of mass litigators even more emphatically than CAFA has.
April 30, 2008
The Hon. Sam C. Pointer, Jr. (1934-2008)
Judge Sam Pointer passed away on March 15. In his thirty years as a federal judge in Alabama, he made his mark in both civil rights and complex litigation. Readers of this blog may know him best for his work as the MDL judge in the silicone gel breast implant litigation. In that litigation, he took the path-breaking step of appointing a national science panel of court-appointed experts to weigh in on the question of medical causation. Judge Pointer served as chair of the Advisory Committee on Civil Rules, and was a major author of the Manual for Complex Litigation. Here's the Washington Post obituary and an announcement from Lightfoot, Franklin & White, where Judge Pointer practiced after he left the bench in 2000.
March 27, 2008
FDA Proposes Guidelines for Drug-Coated Stents
Article in the Wall Street Journal -- FDA Proposes Stent Guidelines, by Jennifer Levitz. Here's an excerpt:
The Food and Drug Administration proposed tougher clinical-trial guidelines for drug-coated stents in response to concerns about blood clotting in the artery-opening devices long after implantation.
The move is the first concrete change since the FDA held a two-day meeting in December 2006 about whether such stents increase the risk of clots compared with bare-metal stents years after the procedure. Coated stents don't appear to increase deaths or blood clots overall; whether they increase late clots years after implantation is still debated.
Instead of assessing patients' progress and health in trials nine months after a stent is implanted, the agency will now require companies to submit trial data on patients' health one and two years after the procedure, before stents can be approved. The new draft guidelines appear to codify standards that the FDA used to assess trials for new stents from Medtronic Inc. and Abbott Laboratories.
February 28, 2008
AEI Panel on Federal Preemption and the Supreme Court
The American Enterprise Institute has posted the audio and video for its panel presentation on February 21 on Federal Preemption and the Supreme Court. AEI's Ted Frank moderated the panel, which included Michael Greve (AEI), Catherine Sharkey (NYU), Daniel Troy (Sidley Austin), and Brian Wolfman (Public Citizen).
February 27, 2008
Nagareda on Preemption in Riegel
Professor Richard Nagareda (Vanderbilt) comments in a Federalist Society SCOTUScast on the recent U.S. Supreme Court preemption decision in Riegel v. Medtronic.
February 20, 2008
Supreme Court Embraces Medical Device Preemption
The Supreme Court today decided Riegel v. Medtronic, an important case concerning federal preemption of state law product liability claims. Justice Scalia wrote for the 8-1 majority in favor of preemption, reasoning that experts at the FDA are better positioned than jurors to evaluate the risks and benefits of medical devices. Justice Ginsburg dissented. Here's a copy of the opinion on Findlaw. And here's an excerpt from David Stout's story in the New York Times, Justices Make It Tougher to Sue Medical Device Makers:
In a case with huge implications for the health care-technology industry, the Supreme Court ruled on Wednesday that the manufacturer of a federally approved medical device cannot be sued under state law if the device causes an injury.
The 8-to-1 ruling in favor of Medtronic, the Minneapolis-based maker of cardiovascular devices, made it much more difficult for patients and their families to sue makers of medical devices that have been granted federal approval. ...
The Supreme Court upheld the lower federal courts on Wednesday, with Justice Antonin Scalia writing for the majority that Medtronic and other manufacturers were protected under the Medical Device Amendments of 1976, which in its section on pre-emption bars states from imposing on medical devices “any requirement which is different from, or in addition to, any requirement applicable under this chapter.”
But the justices’ ruling was hardly the last word on when F.D.A. approval bars patients from suing. They are already considering at least three cases involving drugs and drug-labeling.
January 18, 2008
Supreme Court Grants Cert in Two Preemption Cases
The Supreme Court today granted cert in two preemption cases that will have significance for mass tort litigation. In Wyeth v. Levine, No. 06-1249, the Court will decide whether the FDA's prescription drug labeling judgments preempt state law liability claims for failure to warn. In a case involving Wyeth's anti-nausea drug Phenergan, the Vermont Supreme Court ruled that the FDA regs only provide a floor on labeling requirements, so states are free to enforce their own. In Itria Group v. Good, No. 07-562, the Court is asked to decide whether federal law preempts state-law challenges to FTC-authorized statements in cigarette advertising about "light" or "low tar" cigarettes.
You can see brief descriptions of these cases on ScotusBlog. I'm sure more will follow from the defense perspective on the Drug and Device Law blog. Public Citizen is a good resource for the consumer's perspective on this issue.