Bard Seeks Summary Judgment in IVC Filter MDL with Novel Preemption Argument

Bard IVC filter
IVC filters cause injuries from migration downward and upward. The IVC Filters can also tilt or shift, making them almost impossible to remove.

In a gambit to dismiss 1,700 lawsuits against its IVC filter, CR Bard is pressing a novel argument that the FDA’s quickie 510(k) approval process has become more rigorous, thus entitling it to a ruling that the plaintiffs’ state-law claims are preempted by federal law.

The argument is a stretch because courts have often declined to hold claims preempted where medical devices were cleared under the shortcut 510(k) process, as opposed to the more rigorous premarket approval (PMA) process.

All of Bard’s IVC filters involved in MDL 2641 – the Recovery, G2, G2, Express, G2 X, EclipseTM, Meridian, and Denali Filters — got approval via the lenient 510(k) process. The case is IN RE: Bard IVC Filters Products Liability Litigation, Case No. 2:15-MD-02641-DGC before US District Judge David G. Campbell in Arizona.

Changed greatly?

Bard argues in its summary judgment motion that the plaintiff’s master long and short form complaints, asserting state-law claims, are expressly and impliedly preempted by federal law.

FDA approval through Sec. 510(k) of the Medical Device Amendments of 1976 merely requires that a new device is “substantially equivalent” to a predicate device — but not a review of its safety or efficacy as would happen in a premarket approval application (PMA).

“The 510(k) program has changed greatly since Lohr (Medtronic v. Lohr, 518 U.S. 470 (1996),” Bard argues. “In 1990, Congress dramatically altered the 510(k) process in section 12 of the SMDA (Safe Medical Devices Act). The language expressly linked FDA substantial findings to “safety” and “efficacy”/”effectiveness”:

[T]he term “substantially equivalent” or “substantial equivalence” means . . . that the device . . . (ii)(1) has different technological characteristics and the information submitted . . . contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and efficacy than the predicate device.

Bard says that in its 510(k) approvals:

  • The FDA required compliance with special controls.
  • FDA required Bard to conduct clinical studies of its filters.
  • FDA required additional testing, labeling, and other information during its review.

“These device-specific guidances are intended to address specific risks or issues related to specific devices or device types, and where, as here, FDA has required manufacturers to follow them, they become device-specific federal requirements entitled to preemptive effect,” Bard asserts.

Bard quotes an FDA  2010 Working Report, saying that “the 510(k) program has changed significantly since its inception…. Through various statutory and regulatory modifications over time, it has become a multifaceted premarket review process that is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness, and to facilitate innovation in the medical device industry.”

Similar argument failed

A similar argument failed in a motion for summary judgment by Janssen in IN RE: Xarelto (Rivaroxaban) Products Liability Litigation. In that case, US District Judge Eldon Fallon ruled:

“The Court in Levine [Wyeth v. Levine, 555 U.S. 555 (2009)] held that a state failure to warn claim against a brand-name drug manufacturer was not preempted by federal law, finding that Congress had clearly intended the judicial branch to work in concert with the FDA to protect against unnecessary risk,” the court held.

The judge added, “The court in Guidry [Guidry v. Janssen Pharms., Inc., No. 15-4591, 2016 U.S. Dist. LEXIS 115447, at *48 (E.D. La. Aug. 29, 2016)], relying on Wyeth, found that Plaintiff’s pre-market defective design claims under the LPLA [Louisiana Products Liability Act] were not preempted. “Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable, and perhaps necessary to protect the public health and assure the safety, effectiveness, and reliability of drugs.”

Plaintiffs argue that IVC filters cause injuries as follows:

  • Migration downward and upward. The IVC Filters can tilt or shift, making them almost impossible to remove.
  • Device fracture, causing blood clots (embolism) in the heart, lung, liver and kidneys. Research shows that the devices experienced fracture rates of 37% to 40% after five and a half years.
  • Perforation, where stress on the IVC Filter struts leads to fractures that puncture adjacent organs and vessels.

Read More

Court Shoots Down Preemption Claim as Xarelto Bellwether Trial Nears

xarelto-bleedingShooting down a preemption argument in a defense summary judgment motion, US District Judge Eldon E. Fallon allowed plaintiffs’ state-law design-defect claims against Xarelto to go ahead against Janssen Pharmaceuticals and Bayer Parma Inc.

The plaintiffs’ success came IN RE: Xarelto (Rivaroxaban) Products Liability Litigation, consolidated in MDL 2592 in Louisiana were 16,285 case are pending. As a bellwether trial is looming in federal court in New Orleans, the makers of Xarelto are facing $2.5 billion in potential liability from patients who suffered uncontrollable internal bleeding.

Impossibility argument

The defendants argued that the defective design claims are preempted by federal law, and that it would be impossible for them to simultaneously comply with both federal and state law. But the judge didn’t buy the argument.

“Impossibility pre-emption is a demanding defense,” the court said. “While this Court acknowledges that pharmaceutical companies generally cannot take unilateral action or alter an FDA-approved drug, Defendants are stretching the law beyond its current bounds.”

“The Court in Levine [Wyeth v. Levine, 555 U.S. 555 (2009)] held that a state failure to warn claim against a brand-name drug manufacturer was not preempted by federal law, finding that Congress had clearly intended the judicial branch to work in concert with the FDA to protect against unnecessary risk,” the court held.

It added, “The court in Guidry [Guidry v. Janssen Pharms., Inc., No. 15-4591, 2016 U.S. Dist. LEXIS 115447, at *48 (E.D. La. Aug. 29, 2016)], relying on Wyeth, found that Plaintiff’s pre-market defective design claims under the LPLA [Louisiana Products Liability Act] were not preempted. “Federal law does not prevent a drug manufacturer from complying with this state-imposed duty before seeking FDA approval. Far from impossible, the two are complimentary, preferable, and perhaps necessary to protect the public health and assure the safety, effectiveness, and reliability of drugs.”

One size fits all?

Janssen and Bayer market Xarelto as a one-size-fits-all anticoagulant. Patients take one 20-milligram dose of Xarelto once a day and do not need to undergo routine monitoring. The plaintiffs contend that, because each person processes and metabolizes Xarelto at a highly-individualized rate, each patient’s reaction to the drug is decidedly variable, causing some patients to experience major bleeding events.

The plaintiffs acknowledge that the FDA approved Xarelto’s dosing and monitoring scheme. However, they claim that, given the high inter-patient variability, Xarelto is unreasonably dangerous in design because:

  1. Defendants should have designed, but failed to design, a Xarelto-specific Anti-Factor Xa assay so doctors could monitor Xarelto’s anticoagulation effect on each patient and could, along with the patient, weigh the risks and decide whether to continue taking Xarelto.
  2. Defendants have not designed and marketed an antidote to counteract a major bleeding event.
  3. In the absence of a Xarelto-specific Anti-Factor Xa assay, Xarelto’s label should have warned doctors about the availability of the Neoplastin PT test to measure patient’s anticoagulation.

“Because Defendants did not take any of the above three actions, Plaintiffs claim Xarelto is unreasonably dangerous under the LPLA,” the judge said.

 

Read More

3d Circuit: Preemption Issue is Question of Fact for Jury, Not Legal Issue for Judge

Plaintiff attorney Ryan L. Thompson of Watts Guerra in San Antonio, TX
The Fosamax decision is good news for Plaintiff attorney Ryan L. Thompson of Watts Guerra in San Antonio, TX.

In a far-reaching opinion, the Third Circuit US Court of Appeals revived 5,000 product liability cases involving the osteoporosis drug Fosamax, ruling that federal preemption of state-law claims is a question of fact for a jury to decide, not a question of law for a judge.

The ruling in In re Fosamax Products Liability Litigation, Case No. 14-1900 et al, decided March 22, 2017, is a major setback for Merck and other Big Pharma companies that seek to torpedo patient claims in summary judgment motions, by arguing that:

  1. State-law failure-to-warn lawsuits are pre-empted by federal law
  2. When there is “clear evidence” that the FDA would not have approved a warning label that the plaintiffs claim is necessary.

On the other hand, the ruling is a boon to plaintiff lawyers who are striving to preserve their lawsuits against preemption attacks that have nothing to do with the merits of the case.

For example, the Fosamax opinion is already being cited in an appeal to the 9th Circuit in Incretin-Based Therapies Products Liability Litigation, MDL 2452 in US District Court for the Southern District of California. In that case, the trial court made a summary judgment ruling in favor of the defendant — including Merck — knocking out the plaintiffs’ state law failure-to-warn claims.

In the Incretin case, Plaintiff attorney Ryan L. Thompson of Watts Guerra in San Antonio, TX, notified the 9th US Circuit Court of Appeals about the Third Circuit’s Fosamax ruling in a March 23 letter, seeking to vacate the trial court’s adverse summary judgment, discovery and disqualification orders.

What is “clear evidence”?

The source of the confusion stems from a fuzzy US Supreme Court Opinion, Wyeth v. Levine, 555 U.S. 555 (2009), that says that state-law failure-to-warn claims are preempted by federal law when there is “clear evidence” that the FDA would not have approved a label change. “This standard is cryptic and open-ended, and lower courts have struggled to make it readily administrable,” the Third Circuit commented.

Resolving the issue, the Third Circuit held that “The meaning of “clear evidence,” as Supreme Court usage confirms that the term is synonymous with “clear and convincing evidence.” The latter is a well-recognized intermediate standard of proof—more demanding than a preponderance of the evidence, but less demanding than proof beyond a reasonable doubt.”

Edward Braniff of Simmons Hanly Conroy LLC in New York
Edward Braniff of Simmons Hanly Conroy LLC in New York successfully argued the Fosamax case.

Furthermore, the appeals court ruled:

  • Whether the FDA would have rejected a label change is a question of fact for the jury.
  •  At the summary judgment stage, the court cannot decide for itself whether the FDA would have rejected a change, but must instead ask whether a reasonable jury could find that the FDA would have approved the change.
  • A mass tort MDL is not a class action. Merck’s actual burden at the summary judgment stage was to prove that there is no genuine dispute in every single MDL case that plaintiffs’ doctors would have continued to prescribe Fosamax even if a fracture warning had been added to the Adverse Reactions section before May 2009.

The successful argument to the Third Circuit was made by plaintiff attorneys Edward Braniff of Simmons Hanly Conroy LLC in New York, Michael E. Pederson of Weitz & Luxenberg in New York, and Donald A. Ecklund of Carella Byrne Cecchi Olstein Brody & Agnello in Roseland, NJ.

Beginning in 2010, hundreds of plaintiffs filed personal-injury suits against the drug manufacturer Merck Sharp & Dohme, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures.

Each Plaintiff brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk of thigh fractures to Fosamax’s FDA-approved drug label. Many Plaintiffs also filed additional claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.

Plaintiffs’ suits were consolidated for pretrial administration in a multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the District Court granted Merck’s motion for summary judgment and dismissed all of Plaintiffs’ claims on the ground that they were preempted by federal law.

Fosamax is a treatment for osteoporosis, but plaintiffs claim that the drug actually increases the risk of thigh bone fractures. Plaintiffs claim that while stress fractures typically heal on their own, “some Fosamax users who develop insufficiency fractures have reduced bone toughness, and Fosamax prevents the normal repair of the fracture.” According to Plaintiffs, these patients may then go on to develop what are known as “atypical femoral fractures”: severe, non-traumatic, low energy complete fractures of the femur.

In 2013, Merck reached a separate settlement of $27 million with 1,200 Fosamax users who suffered necrosis of the jawbone.

Read More