Implant For-Profit Industry Not Deserving of Preemption Protection – Part I

Evelyn Pringle July 9, 2007

In addition to the question of how many soldiers will be dead or injured by the time self-proclaimed “war President” George Bush leaves office, Americans need to ask themselves how many citizens will be dead or injured as a result of an FDA controlled by the industry most credited with funding his move to the White House.

Last year, the FDA announced that the agency’s approval of a pharmaceutical product preempts product liability lawsuits against the industry giants in state courts, even when a company actively conceals information that shows serious injury and death are known to be associated with a product.

With the solid backing of the FDA, preemption is now being used as an argument to dismiss lawsuits filed by injured citizens in state courts against medical device makers.

Critics point out that many risks associated with a new product will not be known at the time of FDA approval and that additional safety information often surfaces only after a device is widely used on the market.

Furthermore, FDA regulations allow device makers to add stronger warnings when a risk becomes known, without requiring FDA approval. However, all too often, company documents which surface as a result of litigation show that the device maker was aware of safety risks long before the product was approved and that they actively concealed the information from the FDA.

Legal experts say the legal remedies available under state laws are set up to give additional protection to consumers over and above the minimal protection provided by the FDA approval process, and especially at times like this, when the FDA is run by appointed industry insiders who refuse to police the medical device industry.

The Medical Device Amendments to the Federal Food, Drug and Cosmetic Act establish a federal statutory and regulatory scheme governing the sale of devices in the U.S., but the MDA provides no private cause of action against device makers and therefore, the preemption of state law claims would eliminate most, if not all, legal remedies for persons injured by defective products.

Whether or not the administration has succeeded in immunizing device makers will likely be known in 2008, because on June 25, 2007, the U.S. Supreme Court agreed to hear an appeal in Riegel v Medtronic, involving a case against Medtronic which could determine whether patients will have the right to file lawsuits against device makers under consumer protection laws enacted by the individual states.

The Public Citizen Litigation Group is representing Charles Reigel, who was injured in 1996 when a balloon catheter burst while he was undergoing an angioplasty, a procedure used to open clogged arteries.

After the Second Circuit Court found the lawsuit was preempted based on FDA approval, Public Citizen attorneys Allison Zieve, Wayne Smith and Brian Wolfman, filed a petition asking the Supreme Court to consider whether the Food, Drug, and Cosmetic Act expressly preempts state-law actions brought by patients who have been injured by devices that received pre-market approval, and to issue a ruling due to the inconsistent rulings on the preemption issue in cases filed in the lower courts.

The petition argues that the FDA has switched positions on whether pre-market approval preempts state law claims since the government’s views were solicited by the Court in 1997, when the FDA supported the right to pursue state law claims.

The Supreme Court asked the Solicitor General to offer the government’s views and, of course, the FDA used tax dollars collected in large part from the injured plaintiffs who might have cause to file claims in state courts, to send up a brief that backed Medtronic 1000% in it use of preemption to prevent Americans from suing the device giant.

In direct harmony with Medtronic, the FDA brief tells the Court not to bother with the conflict in preemption rulings in the lower courts because there are now more rulings on one side of issue than the other.

“Also like Medtronic,” Public Citizen responds in a reply brief, “the government asks the Court to overlook the undisputed conflict because it might simply go away.”

“What has changed since 1997,” Public Citizen notes, “is the government’s view on the merits of the question presented.”

“The government’s inconsistency on this question of statutory meaning only underscores the need for this Court to resolve the question presented,” the brief states.

Legal experts say the ruling in this case has the potential to affect thousands upon thousands of lawsuits currently filed in state courts against the makers of medical devices, including defective products implanted in patients with heart disease, such as defibrillators, pacemakers and drug-eluding stents, and devices used during spinal surgery.

A favorable ruling for Medtronic could literally save Boston Scientific from the poor house because, at last count, the company was facing over 75 class actions and 1,100 individual lawsuits involving defective defibrillators and pacemakers manufactured by the recently-acquired Guidant Corp, according to Boston’s SEC filing.

Also, the number of litigants against Boston is rising by the month. On June 15, 2007, the Brown & Crouppen law firm of St Louis filed a 39-count product liability lawsuit in St Clair County on behalf of 14 plaintiffs against Guidant, Boston and Cardiac Pacemakers, alleging the defibrillators/pacemakers were defective and required them to be hospitalized.

These latest lawsuits claim the devices were defective in design, did not conform to federal requirements and subjected users to risks of heart attacks, death and other illnesses that exceeded the benefits of the devices. Other safer products were available, and the makers actively concealed the product defects in order to prevent adverse publicity.

According to the June 29, 2007, Madison St Clair Record, this is at least the third complaint filed by Brown & Crouppen against these same companies.

Spinal surgery represents another division of the implant for-profit industry. A study in the November 2006 Spine journal, conducted at Dartmouth Medical School, analyzed data on lower back (lumbar) surgery among Medicare recipients aged 65 and older nationwide and found that surgery rates in 2002-2003 were almost 8 times higher than in 1992 in some areas of the U.S., and in 2003, Medicare spent over $1 billion on spine surgery.

On August 5, 2006, the LA Times reported that spinal surgery has become a very lucrative business, “with at least $3.2 billion spent last year in the U.S. on spinal fusion.”

In October 2004, Johnson & Johnson obtained FDA approval for the Charite artificial spinal disc as an alternative to spinal fusion surgery, but experts contend that the superiority of the two procedures is limited to the cost. Charite replacement can run as high as $50,000, while spinal fusion surgery costs less than half that, at roughly $23,000.

A favorable ruling on preemption would be great news for Johnson & Johnson, considering that SEC filings reveal that there were 100 lawsuits pending against the company at the end of 2006 related to the Charite artificial spinal disc, alleging that the company knew the disc was defective and boosted profits by implanting the device for uses not approved by the FDA and in patients who would not benefit from the device.

Between the time the disc was approved in October 2004 and July 2006, the FDA had already received over 130 reports of serious adverse events in patients implanted with the device and, in most cases, the disc was implanted in patients who did not meet the criteria for disc replacement as specified by the FDA.

Although a favorable Supreme Court ruling would be beneficial to the device makers in dealing with lawsuits filed by private plaintiffs in state courts, it will do nothing to stop the on-going investigations into the marketing of devices to determine whether device makers are funneling money to doctors and hospitals to increase the use of their products.

Anti-kickback statutes make it illegal for doctors or medical facilities to receive financial incentives to increase the use of devices, which in turn increase the number of implant procedures, in patients covered by public health care programs.

In the end, it was the greed, evidenced by drastic rise in the use of not only defibrillators and pacemakers, but all medical devices with Medicare patients over the past few years that drew the attention of lawmakers and law enforcement officials to the implant for profit industry.

On September 26, 2006, the New York Times reported that overall, Medicare payments to hospitals for implant procedures grew from $10 billion to $14 billion, an increase of about 40%, in just 2 years.

As of today, every major device maker is under investigation for working with doctors and hospitals to increase profits by billing public health care programs for implant procedures performed on patients who, in many cases, did not need the devices.

The FBI, the U.S. Department of Justice and the Department of Health and Human Services have set up a Medicare Fraud Strike Force, and the Strike Force is predicting that as much as $2.5 billion can be saved by cracking down on the device makers, doctors and hospitals involved in the implant industry.

The investigations of J&J and its DePuy Division are not limited to the Charite disc. In June 2006, the company was served a subpoena by the Antitrust Division of the DOJ, requesting documents related to the manufacture and sale of the company’s orthopedic devices, and search warrants were executed in connection with the investigation, according to documents filed by J&J with the SEC on August 8, 2006.

SEC filings also show that Medtronic is responding to a subpoena from the Office of the U.S. Attorney for the District of Massachusetts, issued under the Health Insurance Portability & Accountability Act of 1996, requesting documents relating to pacemakers and defibrillators; monitoring equipment and services; benefits to persons in a position to recommend purchases of such devices; and the company’s training and compliance materials relating to the fraud and abuse and federal Anti-Kickback statutes.

Investigations are also underway into over-use of the new drug-eluting stents (DES), marketed by Boston and Johnson & Johnson, with the average cost to Medicare ranging from $11,184 to $14,287, according to the Centers for Medicare and Medicaid Services.

The first DES was approved in 2003, and on December 4, 2006, Bloomberg reported that, in 2005, the new stents accounted for 43% of total sales for Boston and 52% for Johnson & Johnson. By the end of 2006, the new stent was a top-selling device for Boston, bringing in about $2 billion.

On March 1, 2007, the House Oversight and Government Reform Committee, which conducts oversight of Medicare spending, ordered Johnson & Johnson and Boston to turn over documents, related the marketing of drug-eluting stents.

In May 2007, the Strike Force reported that one Maryland cardiologist had implanted 25 unnecessary stents in 2006, with most patients covered by Medicare.

The salary for the cardiologists who benefit from stent procedures is roughly half-a-million dollars a year, according to an article in Slate Magazine on May 8, 2007.

Legal analysts are predicting that the lawsuits filed by patients injured as a result of the massive over-use of medical devices will involve all the co-conspirators in the medical profession who helped turn the implant business into a billion-dollar industry overnight.

Calls for End to Medical Device Maker Immunity

Evelyn Pringle May 13, 2009

On May 12, 2009, the House Energy and Commerce Subcommittee on Health held a hearing on the Medical Device Safety Act of 2009. HR 1346 would overturn the February 2008 Supreme Court decision that, for the first time, denied patients the right to sue device makers for compensation when injured by certain medical devices.

In the case of Riegel v Medtronic, the court ruled that a device maker cannot be sued under state law by patients alleging injury from a device that received marketing approval from the FDA.

“The Court’s decision has left consumers without any ability to seek compensation for their injuries, medical expenses and lost wages resulting from injuries caused by defective premarket approval (PMA) devices or inadequate safety warnings,” according to a March 5, 2009 press release by Representatives Frank Pallone, Jr (D-NJ), Chairman of the Energy and Commerce Subcommittee on Health, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, issued when introducing the Medical Device Safety Act of 2009.

“It also removed one of the industry’s most important incentives to maintain product safety after approval and disclose newly-discovered risks to patients and physicians,” the release noted.

A companion bill has been introduced in the Senate by Senators Edward Kennedy (D-MA) and Patrick Leahy (D-VT).

Dr Gregory Curfman, executive editor of the New England Journal of Medicine, testified at the hearing from prepared remarks and urged Congress “to swiftly pass” the legislation and stated in part:

“This bill would nullify the Court’s ruling in Riegel by adding language to the Medical Device Amendments to make explicit that the law does not preempt suits against device companies and thereby to place medical devices and drugs on a level playing field with respect to patient lawsuits.”

“The critical issue of preemption, which directly affects the disclosure of risks and thus the safety of the nation’s supply of medical devices and drugs, should properly be decided by officials elected by the people, with whom the responsibility for the health of the public rightfully resides.”

On March 31, 2009, a group of medical device patients from around the country traveled to Washington to ask Congress to pass the Device Safety Act, as part of the “Campaign to Stop Corporate Immunity,” a coalition of consumer, health, and trade associations fighting to restore the rights of patients injured by faulty devices.

In a March 31, 2009 letter to Congress, the patient group explained in part: “The Medical Device Safety Act will return our rights that have been taken away by fixing this problem and putting the law back the way it was just over a year ago.” 

“Most of us here today have received a Medtronic Implanted Cardiac Defibrillator (ICD) that had a defective Sprint Fidelis lead attaching it to our hearts. This lead has malfunctioned causing patients like us to suffer unnecessary shocks that can only be compared to getting kicked in the chest by a horse. While these are meant to be life saving devices, some of us are here representing loved ones who lost their lives as a direct result of their defects.”

“Medtronic knew this lead was faulty and failed to report problems to the FDA. As a result, hundreds of the defective leads were implanted in heart patients across the country. This was all before they had immunity from lawsuits! Imagine how reckless they will be with out the checks and balances of our civil justice system.”

“If we cannot hold medical device manufacturers accountable for their actions, we cannot pay for our medical care, a cost that will fall to taxpayers. Why should Americans have to finance the medical device industry?” 

“Please, consider us when it comes time to vote on the Medical Device Safety Act, and vote YES for patient safety.”

A day earlier on March 30, 2009, the Center for Justice & Democracy released a study titled, “HEART SICK Hazardous Heart Devices and the Importance of Litigation,” and pointed out that while “saving many lives, heart implants are also among the most dangerous and recalled medical implants ever made.”

“This study tells a devastating tale of greed, cover-ups and reckless behavior by some companies that manufacturer heart devices, such as pacemakers, defibrillators, heart valves and stents,” said Joanne Doroshow, Executive Director of the Center, in a press release.

“Some of these devices were placed on the market without adequate testing,” she continued. “This has been with the acquiescence of the Food and Drug Administration, which has repeatedly been unable to properly oversee this hazardous industry.”

“Heart devices have saved millions of lives, but hundreds of thousands have malfunctioned due to design and manufacturing defects that should have kept these devices off the market,” said report author Amanda Melpolder in the press release.

“When they fail, the results for patients can be catastrophic,” she advised. “Only through litigation have patients and their families been compensated, and in many cases, lawsuits have been the only way information has come to light about some of the most dangerous heart devices.”

“Because of medical risks, heart implants are not always removable even if the device fails or is later recalled,” the summary on the study points out. “Sometimes devices are recalled long after manufactures were aware of problems and tens of thousands of devices are implanted in patients, forcing them to live with ticking time bombs in their chests.”

“Time and again, medical device companies have shirked their responsibilities to ensure the safety of heart devices,” the summary notes.

At the subcommittee hearing, Professor of Law at Georgetown University Center, David Vladeck, testified from prepared comments and point out that:

“Riegel has already been invoked to dismiss claims involving defective defibrillators, defibrillator cables, hip replacements (even though the model was recalled), knee replacements, heart valves (also subject to recall), silicon breast implants, and “adhesion barriers” used in surgery.”

“All of these case would have been viable prior to Riegel,” he said.

“Because of the structural limitations in the preapproval process,” Professor Vladeck advised, “FDA’s track record demonstrates the agency’s inability to single-handedly protect the American people against defective and dangerous medical devices.

Just in the past few years, he said, we have seen massive recalls of defibrillators, pacemakers, heart valves, heart pumps, and prostheses — “which have exacted a terrible toll on the patients who have had them implanted in their bodies, and who often face the daunting prospect of explantation and replacement surgery.”

“Post-Riegel, these patients will now be left with no remedy at all: no compensation for the pain and suffering they endure, no reimbursement for the expenses of surgery, no reimbursement for lost wages, and no recompense to their loved ones should they die as a result of a defective device,” he pointed out.

On its website, the Stop Corporate Immunity group explains that: “When patients with devastating injuries are unable to hold the negligent manufacturer accountable, the patient and the taxpayers are left footing the bill.”

“For a patient with private health insurance, the health insurance would most likely cover the additional surgery. However, this raises the cost of insurance, and still leaves the patient with no compensation for the physical limitations caused by the device’s failure.”

“For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed to the taxpayers. And for patients who can no longer work, they may need additional taxpayer supported programs, such as Social Security disability.”

“All this cost shifting,” the group says, “does nothing to help the injured patient, drains public funds, and does not encourage the manufacturer of the faulty device to fix the problem.”

“A quarter of a million people received the Sprint Fidelis cable in the three years from its introduction in 2004 until Medtronic “recalled” the product in 2007 because of its high failure rate,” Professor Vladeck told the committee.

“Although Medtronic has admitted that the Sprint Fidelis cable has a dangerously high fracture rate,” he said, “it has offered patients no financial assistance at all other than the cost of the replacement cables.”

“Patients alone must bear the full costs of the surgery — which can run as high as $15,000 — the recovery, the lost time from work, and the pain and suffering they endure,” he explained.

Four patients have already died during extractions, and at least nine others have died as a result of the device’s defect. “The FDA has received 2,200 reports of serous injuries associated with the cable’s failure,” the Professor reported.

“The most patients can hope for is that some of their medical costs will be offset by private insurance or by Medicare,” he said.

“Medtronic has offered nothing more to patients and post-Riegel patients stuck with a Sprint Fidelis cable cannot compel Medtronic to do more,” he added.

“Consumers, like the thousands of patients struggling to decide whether to undergo risky extraction surgery with the Sprint Fidelis cable, are left with the worst of both worlds,” he advised, “an FDA premarket approval system that cannot possibly guarantee the safety of devices and no recourse if their devices fail.”

In June 2009, Professor Vladeck will take a leave of absence from the Georgetown Center to join the Federal Trade Commission as Director of the Bureau of Consumer Protection.

The Medical Device Safety Act is endorsed by the National Conference of State Legislatures, the New England Journal of Medicine, the American Bar Association, AARP, the Center for Justice & Democracy, Consumer Federation of America, Consumers Union, Homeowners Against Deficient Dwellings, National Association of Consumer Advocates, National Consumers League. OWL – The Voice of Midlife and Older Women, Progressive States Network, Public Citizen, and the National Research Center for Women & Families