Depuy Hip Recall Lawyer

We have a fair number of hip replacement lawsuits at the firm, so we follow all of the news related to them, including last week’s article in the New York Times about “The High Cost of Failing Artificial Hips“, which included a key point that hasn’t received much attention in the press:

In August, Mr. Dougherty underwent an operation to replace a failed artificial hip, but his pelvis fractured soon afterward. The replacement hip was abandoned and then a serious infection set in. Some of the bills: $400,776 in charges related to hospitalizations, and $28,081 in doctors’ bills.

I can guarantee you Mr. Dougherty’s insurer, hospital, and orthopedic surgeon don’t plan on taking payment in flowers and boxes of chocolate notes. As the article continues:

The incidents have set off a financial scramble. Recently, lawsuits and complaints against makers of all-metal replacement hips passed the 5,000 mark. Insurers are alerting patients that they plan to recover their expenses from any settlement money that patients receive. Medicare is also expected to try to recover its costs.

While his insurer has covered his bills so far, Mr. Dougherty said he was preparing to sue his surgeon, who may have implanted the device incorrectly, and Johnson & Johnson, which produced his artificial hip, to help recoup some of the insurer’s money.

“All these payers want to be paid back,” said Matt Garretson, the founding partner of the Garretson Resolution Group, a firm in Cincinnati that manages product liability cases.

Perhaps it’s best to explain the situation by explaining what the New York Times means when it says Garretson’s firm “manages” product liability cases. We’ve retained Garretson’s firm in the past: they don’t represent clients in litigation, but rather assist plaintiff’s lawyers with “lien resolution,” a multi-billion-dollar industry that deserves a lot more attention from legislators in this day and age.
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[Update: Drug & Device Law has also released their list of “best” cases, and so I have responded.]

First, a bow to my opponent. I reference the pharmaceutical company defense lawyers from Dechert at Drug & Device Law a lot here on this blog even though, as a plaintiff’s lawyer, I’m always on the other side from them (one might even say they’re on the wrong side of the law) because they write a great blog. They write detailed, passionate arguments about substantive issues of law, and they link liberally, involving others in the conversation. It’s not that I haven’t noticed you folks over at Weil Gotshal with your competing Product Liability Monitor (link nofollowed), but you need to add some hot sauce and link out if you want to roll with the big boys. Maybe it’s because Dechert’s in Philadelphia and Weil Gotshal’s in New York, or maybe it’s because we Philadelphia lawyers punch a little bit harder.

Now, on to the fight. Drug & Device Law has compiled their “Ten Worst Drug/Medical Device Decisions of 2011.” It must have been a Herculean task: from my perspective, you have to look really hard to find court decisions against the pharmaceutical and medical device industry. As I’ve written before, the deck is stacked against innocent people injured by these drugs and medical devices: it’s almost impossible to sue pharmaceutical companies for anything other than inadequate warnings on their labels (a claim that is itself in peril, even as drugs like ActosPradaxa, and Propecia warn of their minor risks but not their major risks), and it’s virtually impossible to sue implant and medical device manufacturers for anything other than violating FDA regulations.

Of course, none of the court opinions on the D&D Law list were really against the drug and medical device companies; no court ever rules that a drug company was negligent or that medical device company has to pay compensation. When a plaintiff “wins” a court decision, that really means the plaintiff gets a chance to prove their case in front of a jury. Instead, when drug and device companies complain about courts, it’s because they think the court should have dismissed the cases entirely, without a trial, without a word of testimony or a shred of evidence shown to a jury. The bulk of the cases cited by Drug & Device Law follow that pattern, with the defense lawyers complaining either that a court didn’t buy some preposterous defense theory or that a court didn’t let a company walk away scot-free after violating FDA regulations and hurting people.

Indeed, the D&D Law list of cases is revealing because of just how reasonable these “worst” court opinions are.  There’s been a lot of press lately about how more Americans are killed annually by prescription medication overdoses than car accidents; coincidentally, D&D Law’s “worst” decision of the entire year, DiCosolo, involved a consumer indisputably killed by a defectively manufactured prescription painkiller patch, and they argue we’re supposed to let the maker of that deadly product walk away from any accountability because the DiCosolo’s weren’t compulsive hoarders that held on to every used disposable product in their house? Because Janssen Pharmaceuticals failed to convince a jury of its ridiculous fentanyl fairy theory? What’s so wrong with letting a jury hear those factual arguments and deciding what’s true and what’s not, the way we’ve settled disputes since ancient times?

Let’s unpack a couple of these “worst” opinions and see just how bad they really are. 
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Another day, another multi-billion-dollar industry looking for a handout.

This time it’s the Wall Street hedge funds and venture capital funds — you know, the ones that talk “free market” but somehow always need government assistance — that have invested heavily in medical device manufacturers:

As Congress considers reauthorizing a law that sets the fees for medical device makers, venture capitalists are emerging as a rich and influential ally of device companies eager to remove what they say are regulatory roadblocks in the approval process. The push has alarmed patient advocates and some doctors, who have been calling on the F.D.A. to intensify its oversight of devices, particularly in light of some all-metal artificial hips that are failing prematurely at an unusually high rate.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

The New York Times found that “people associated with funds that underwrite companies developing new devices and other health products have made more than $3.3 million in political donations to Republicans, Democrats and political action committees over the past five years.” Shocking, I know.

Take a look at how thoroughly the Republican-controlled House of Representatives examined the issue:

Since February, four House panels have held hearings on the impact of F.D.A. procedures on device approval. At those sessions, 19 of the 26 listed witnesses were investors, entrepreneurs, industry consultants, trade group officials or patients who said that agency delays in approving a device had harmed them or a loved one. The list included no patients injured by a flawed device; one hearing in the Senate had a more varied witness list. Two weeks ago, four Democratic congressmen wrote to their Republican counterparts about the imbalance in the House testimony and suggested the hearings had failed to address potential dangers “if medical devices are not appropriately regulated.”

(Emphasis mine.)

Not one. A little over a year ago, Johnson & Johnson and the FDA announced the recall of nearly 100,000 defective DePuy hip replacement implants because the metal-on-metal bearings degrade and release metal shavings into surrounding tissues and patient’s bloodstreams, requiring revision surgery and treatment for blood poisoning, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.

Maybe Congress thought that was an exception and all the other medical implants are totally safe. So what about July of this year, when the FDA reported:

In October 2008, the FDA issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, and to provide recommendations on how to mitigate risks and how to counsel patients.  Following the PHN, the FDA continued to monitor the outcomes of urogynecologic use of surgical mesh.  A search of the FDA’s Manufacturer and User Device Experience (MAUDE) database from the last 3 years (January 1, 2008 – December 31, 2010), identified 2,874 Medical Device Reports (MDRs) for urogynecologic surgical meshes, including reports of injury, death, and malfunctions.  Among the 2,874 reports, 1,503 were associated with pelvic organ prolapse (POP) repairs, and 1,371 were associated with stress urinary incontinence (SUI) repairs.

Just under 3,000 vaginal mesh problems because the surgical mesh eroded the vaginal wall causing painful sexual intercourse, infection, urinary problems, vaginal shrinkage, bleeding, and organ perforation, but the Republicans in Congress apparently couldn’t find a single person who felt strongly enough about that to testify.

Or maybe the Republicans in Congress didn’t want to hear what patients and their advocates might say: the FDA does too little to ensure medical devices are safe. The FDA needs more regulations, not fewer.

The Depuy ASR hip implant and transvaginal mesh implant debacles both had the same cause: the 510(k) clearance loophole. Under that loophole, if a medical device manufacturer can convince the FDA that the implant is “substantially equivalent” to something else on the market, then it’s approved, even without any actual testing to see if it’s safe or even useful.

It’s a bad idea, which is why the Institute of Medicine — which investigated 501(k) clearance at the request of the FDA — recommended the process be abolished. Consider this depressing section from the FDA’s safety update on transvaginal mesh placement:

Surgical mesh products are currently regulated as Class II devices and are reviewed under the 510(k) Premarket Notification Program.  The FDA’s premarket review of these devices has primarily focused on data supporting the adequacy of mechanical performance and material safety.  Bench and/or animal testing have been used to confirm that engineering specifications are met and that the mesh material is biocompatible.  Clinical performance data typically has not been used to support clearance for POP or SUI urogynecologic mesh products.

In other words, they just checked to make sure the transvaginal surgical mesh was made like normal surgical mesh. The FDA didn’t even bother to review “clinical performance data” on actually implanting the mesh to treat POP or SUI to see if it worked and if it was safe. It just made sure the vaginal mesh looked like surgical mesh and that was that. Those are the ‘overly burdensome’ regulations medical device manufacturers think are too stringent. There are Representatives and Senators who believe we need less FDA regulation?

There’s another important aspect to this debate: medical device manufacturers already have a special exemption from the negligence laws that apply to all the rest of us. Lowering FDA standards will make that special exemption even bigger.

As I’ve written before, it’s already particularly difficult to sue drug makers even for breaking federal law, and some courts are considering eliminating manufacturers’ legal duty to make safe drugs, leaving plaintiffs with a single potential claim, i.e. the “failure to warn” based on the drug maker not honestly describing how dangerous their drugs really are. 
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The Executive Editor of the New England Journal of Medicine recently called the DePuy ASR hip replacement recall a “public health nightmare” and a prime example for why the FDA needs to fix the “510(k) clearance” loophole that allows the sale of certain medical devices — even implants — to be sold without any clinical data or testing. The Institute of Medicine, too, has recently recommended that 510(k) clearance be eliminated.

In the meantime, 93,000 patients are stuck with defective ASR hip replacement implants with a shocking replacement rate: 21% revision rate at 4 years (up to 35% if all currently known painful implants progress to revision) to 49% at 6 years. Other hip replacement devices have a revision rate of 12% to 15% at 5 years. DePuy Orthopedics is negligent and they know it; they spend about a quarter billion dollars every four months dealing with the product recall and the litigation associated with it.

We have an active DePuy hip replacement recall practice around here, so we follow the litigation closely, and yesterday’s report by Reuters discussed one of the more disturbing turns lately:

In a highly unusual move, DePuy has hired a third party — Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers — to administer patient claims for out-of-pocket medical costs associated with the recall.

The move has prompted debate among industry and legal experts. Some see it as an efficient way to outsource a process that is unrelated to making artificial hips. Others see it as a way for J&J to limit payments while gaining control of medical records and other material that could be used against patients in court. …

To critics, DePuy’s handling of its hip implant recall is designed to save money by potentially settling claims with patients before they fully understand their legal rights, or the likely cost of their hip-related medical costs in the future.

Indeed, that’s exactly what Johnson & Johnson (which owns DePuy Orthopedics) and DePuy are trying to do: manipulate patients and their treating physicians outside of the appropriate court processes.
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