Judges: Infuse lawsuits not preempted

Judges: Infuse lawsuits not preempted

August 26, 2013 # 10:18 am # Pharmaceutical Watch # No Comment

Plaintiffs won an important preemption battle in U.S. District Court in Ariz. in August when Judge G. Murray Snow ruled that Medtronic changed the calculus of preemption by breaking federal law in promoting off-label use of Infuse. Consequently, the judge ruled, the company was no longer able to claim immunity by federal preemption.

The court wrote: “In short, the FDA strictly regulates manufacturers based on the intended use of the device, and manufacturers can deviate from those specifications only with permission.”

Lawyers for Medtronic, Inc., had claimed that federal law preempts state law in this case; they argued that because Infuse had been approved by the FDA (in 2003), it was then shielded from liability if it injured anyone. Though shot down in Arizona, that argument appeared to work a week earlier in a court in Minnesota, where Medtronic maintains headquarters.

Minnesota Ruling Differs

In Minneapolis, Judge Laurie Miller ruled in August that federal law will not allow Minn.  courts to hear the cases of dozens of people  injured by Medtronic Inc.’s Infuse spinal device. Judge Miller granted the motion to dismiss based partly on recent U.S. Supreme Court rulings that found medical device makers could not be sued by patients if the  FDA had already approved their products.

This decision was controversial, to say the least. Nevertheless, Judge Miller did leave  the legal door open for plaintiffs to re-plead the cases under different causes of action;  so there is still some hope left for these Infuse-injured people whose cases were filed in Minnesota.

Cook County Ruling also for Plaintiffs

Plaintiffs also won an import decision in July 2013 when a lower court judge in Illinois ruled that a Medtronic Infuse lawsuit can go forward despite defense arguments that the lawsuit is preempted by federal law. The lawsuit alleges that Medtronic promoted unapproved uses of  Infuse Bone Graft and it also alleges faulty labeling.

Eperts say it is illegal for Medtronic to promote Infuse off-label (though it is not illegal for doctors to use a product off label), and Judge Eileen M. Brewer agreed. In Cook County Circuit Court, Judge Brewer denied a defense motion to dismiss a Medtronic Infuse bone graft lawsuit based on the fact that state law claims parallel federal law in this case. Furthermore, the judge ruled that makers of medical devices are not entitled to liability protection if the manufacturer’s failure to follow federal law results in patient injury.

Based on the assumption that the plaintiff’s claims are federally preempted by the Food, Drug and Cosmetic Act, Medtronic filed a motion to dismiss the lawsuit. Judge Brewer, however, ruled that the claims are not preempted, because the off-label use and the promotion of that off-label use violated FDA regulations for the device.

In this  case, the Infuse bone graft injury occurred after a procedure that fused vertebrae in the cervical spine. The lawsuit was filed after plaintiff, Karl Sanda underwent cervical spinal surgery in Jan. 2011. The suit alleges the Infuse bone graft was used off-label based on promotion by Medtronic sales representatives who paid key opinion leaders to promote the off label usage.

Jury awards $2 million in damages in Bard TVM case

Jury awards $250,000 in injury damages and 1.75 million in punitive damages in Bard TVM case

A federal jury in a bellwether injury lawsuit re-trial this week arrived at a $250,000 injury judgment against  transvaginal mesh device maker, C.R. Bard. This Bard case, the first to come before West Virginia’s Federal multi-district litigation (MDL) court, was declared a mistrial last month after testimony revealed the mesh product had been removed from the market, a disclosure which ran afoul of the court’s pre-trial instructions. This time the jury made it to a verdict, which declared C.F. Bard’s Avaulta pelvic mesh device to be defective, and determined that Bard failed to warn about the mesh’s defects.

The jury in the retrial, which began on July 29 and lasted six weeks, awarded the plaintiff $250,000 in compensatory damages, then later added an additional $1.75 million in punishment damages. Though the punitive portions of these damage awards are seldom collected by plaintiffs, the amount in this case clearly indicates that the jury felt the company knew about problems with the Avaulta product, yet failed to properly disclose them to the plaintiff. The jury deliberated for 12 hours over two days. Judge Joseph Goodwin of the U.S. District Court for Western Virginia presided.

Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. Transvaginal mesh devices are supposed to help correct these conditions by providing additional strength to the pelvic walls. These mesh devices were approved through an FDA fast-track process known as 510(k), which requires no formal review for safety or efficacy; consequently, the 510(k) route has drawn criticism for being used to gain clearance for transvaginal mesh and other controversial devices.

This is the first federal lawsuit to come to trial that alleged the device harmed a patient. Myriad companies – including Boston Scientific, Endo Health Solutions, Cook Medical, and Johnson & Johnson’s  Ethicon subsidiary – face more thant 4,000 federal lawsuits related to transvaginal mesh devices.

“The jury award reflected the surgeries the woman suffered post implant and the problems she had pre-implant,” said attorney David Matthews, whose firm of Matthews & Associates, along with Freese & Goss – of Dallas, Texas; Jackson, Miss.; and Mobile, Ala. – will try five mesh cases in the next year.  The firms’ five trial cases, however, all concern mesh slings used for stress urinary incontinence (SUI), as opposed to the mesh which was used, in this West Virginia case, to treat pelvic organ prolapse (POP).

The difference in the types of mesh could be important for trial outcomes. The distinction was made somewhat clear in June 2011 when the FDA announced that it would like to see more testing of the transvaginal mesh used for POP; but the agency essentially seemed to agree with manufacturers that the slings being used for SUI did not require further testing, that slings were the “gold standard” for SUI treatment. Whether the slings’ risks outweigh their benefits and whether the women who have been slinged were properly warned of the dangers in the event of the sling’s failure will be determined in the courts.

The FDA has stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful when compared to alternative methods for treating POP. The FDA also recently reported that the most common complications associated with transvaginal mesh may include:

• Exposure, extrusion, or protrusion (mesh erosion through the vagina)
• Pain
• Infection
• Bleeding
• Pain during sexual intercourse (dyspareunia)
• Organ perforation
• Urinary problems

If you have been injured by a mesh implant schedule your free initial consultation online or call us at 508-499-3366.

Transvaginal Mesh trials in W.Va. MDL

Transvaginal Mesh trials in W.Va. MDL

A jury trial in a lawsuit involving transvaginal surgical mesh pelvic repair products is underway in U.S. District Court in Charleston, W. Va., site of the multi-district litigation (MDL) federal court.

The case is brought by Donna Cisson of Georgia, who is suing C.R. Bard. Inc., for a pelvic mesh implant she received that was made by the company. Ms. Cisson’s  case is the first of thousands of surgical mesh lawsuits filed nationwide to go to trial in the federal W. Va. MDL.

The lawsuits accuse the implants’ manufacturers of inadequate testing, failure to disclose potential risks, fraudulently promotion of the mesh as a safe medical device, and defective product design.

A first trial of Cisson’s lawsuit ended in a mistrial earlier in July.

The Cisson lawsuit is one of four bellwether cases that U.S. District Judge Joseph Goodwin will hear to determine the next step in litigation for the remaining lawsuits.

Another bellwether case against Johnson & Johnson’s Ethicon division in the federal multi-district litigation court (MDL) in West Virginia beginning Jan. 14, 2014.