Pharma Law Post

Pharma Law Post

California Defective Product & Drug Litigation

More Good News Out of California’s Central District in the Vaginal Mesh Litigation

By Stewart R. Albertson on Posted in Product Liability Litigation, Vaginal Mesh Litigation

Some more good news came out of California’s Central District today in the vaginal mesh litigation mess. Federal Judge Philip S. Gutierrez remanded a mesh case back to California State court against the wishes of vaginal mesh manufacturer American Medical Systems, Inc.

Earlier in the year an injured California patient filed suit against American Medical Systems in California State court claiming significant injuries from the manufacturer’s vaginal medical device known as the MiniArc® Sling System. A few weeks later American Medical Systems removed the case the Federal Court claiming that the injured plaintiff did not have a right to file her case in state court.

American Medical Systems arguments were simple enough. It argued that the California doctors who implanted the MiniArc® in the patient were “fraudulently misjoined” in the State suit. It also argued that the case should be stayed and effectively punted to a West Virginia Federal Court.

But Judge Gutierrez disagreed with American Medical Systems’ arguments. He held that the case should not be stayed until it was determined that the Federal Court had jurisdiction over the case to begin with. Since Judge Gutierrez ultimately held that the Federal Court did not have jurisdiction, he did not stay the case. Rather, he sent it back to California where it belongs.

Thus far American Medical Systems has removed five cases from State court to Federal Court involving California patients. Of those five cases, three have been returned to State court. We are still waiting for one more decision to come down, and hopefully we will see that case remanded as well.

Some Good News and Not So Good News Out of California’s Central District Involving Transvaginal Mesh

By Stewart R. Albertson on Posted in Drug & Device Litigation, Product Liability Litigation, Vaginal Mesh Litigation

First, the good news. U.S. District Judge Josephine Staton Tucker remanded a vaginal mesh case back to California state court against the wishes of vaginal mesh maker American Medical Systems. You can see Judge Tucker’s order here.

And, second, the bad news. U.S. District Judge Audrey B. Collins decided not to remand a vaginal mesh case back to California state court. You can see Judge Collins’ order here.

Thus far, we’ve obtained federal court orders remanding three vaginal mesh cases to California state court, namely Goodwin, Lung, and Haston. You can see the Goodwin order above, the Lung order here, and the Haston order here.

There are still two cases that should be decided by the federal court in the next week or so. I’ll update that when it occurs.

The Central District of California Sends Another Invalidly Removed Vaginal Mesh Case Back to California State Court

By Stewart R. Albertson on Posted in Drug & Device Litigation, Product Liability Litigation, Vaginal Mesh Litigation

The vaginal mesh companies procedural gamesmanship continues to fail in the Central District of California. On Monday United States District Judge S. James Otero ordered a transvaginal mesh lawsuit back to California state court against the wishes of vaginal mesh manufacturer C. R. Bard, ruling that a California doctor was not “fraudulently misjoined” as a defendant in the original state court lawsuit. You can see Judge Otero’s order here.

This is a new (not so new now as it’s been copied by every defense firm who chooses to protect dangerous products made by vaginal mesh manufacturers) tactic where mesh companies unilaterally remove a state filed case to federal court claiming that the injured patient “fraudulently misjoined” the in-state doctor who surgically implanted the mesh.

But the “fraudulent misjoinder” doctrine does not apply in California or in the Ninth Circuit for that matter. But that doesn’t stop the vaginal mesh company defense attorneys from making this invalid claim.

The mesh company defense attorneys do this with the hope that the federal court will punt the “fraudulent misjoinder” issue to another federal court located in a far away venue, for example West Virginia. If that happens the West Virginia court is so busy dealing with thousands of other cases filed against the various transvaginal mesh companies, that it does not have time to rule on whether the mesh maker had the right to remove the case from state court to begin with. Voilà, the vaginal mesh company, if successful, just discounted the ultimate amount they’ll pay in damages to the injured California patient to pennies on the dollar.

But in this most recent case remanded back to state court, C. R. Bard’s (a mesh maker) strategy didn’t work in the Central District. Now the injured California patient’s case will be heard in front of a California jury.

Some more good news came out of the Central District of California a few weeks ago when United States District Judge John F. Walter ordered another transvaginal mesh case back to California state court. You can see Judge Walter’s order here.

In that case the defendant was American Medical Systems, who paid their defense attorneys—Reed Smith, LLP—to invalidly remove a case—Haston v. American Medical Systems, Inc.—from state court to federal court. Thankfully in Haston the federal court simply sent the case back to where it belongs—California state court.

American Medical Systems paid its attorneys—Reed Smith, LLP—to invalidly remove four other state-filed transvaginal mesh cases to federal court in late February 2013. The hearings on whether these cases should be sent back to the state courts are coming soon. I’ll provide an update when those cases are decided.

Federal Court Sends Vaginal Mesh Case Back To Riverside County Superior Court

By Stewart R. Albertson on Posted in Drug & Device Litigation, Product Liability Litigation, Vaginal Mesh Litigation

Some great news came down today from the Central District of California regarding a transvaginal mesh case that was recently removed to federal court by American Medical Systems, Inc.’s defense attorneys ReedSmith, LLP. Federal judge John F. Walter ordered the case back to the Riverside County Superior Court. (FYI, the picture to the right is not a picture a judge John F. Walter.)

The case—Haston v. American Medical Systems, Inc. (Case No. RIC 1218837)—was filed in Riverside County Superior Court in early late 2012. On February 27, 2013, American Medical Systems unilaterally removed the case to federal court (Case No. ED CV 13-00364-JFW OPx) alleging that the case could be removed based on diversity of citizenship between the plaintiff and defendant American Medical Systems, Inc.

But there was one glaring problem for American Medical Systems; the plaintiff and another named defendant–the doctor who surgically implanted American Medical Systems’ medical device into the plaintiff–were both California citizens, meaning the case did not qualify for removal to federal court.

But that didn’t stop American Medical Systems from unilaterally removing the case to federal court. American Medical Systems based its removal on “fraudulent misjoinder”of the defendant doctor relying on the so-called Tapscott doctrine that came out of the Eleventh Circuit in 1996. (FYI, we are in the Ninth Circuit in California.)

But the federal court wasn’t buying American Medical System’s unilateral removal to federal court. The federal court, without holding a hearing, remanded the case to California state court. The court based its decision on law school 101 analysis, as follows:

Federal courts are courts of limited jurisdiction, and federal jurisdiction must be rejected if there is any doubt as to the right of removal by American Medical Systems. Additionally, there is a strong presumption that the federal court does not have jurisdiction. Finally, American Medical System, the party invoking federal jurisdiction, bears the burden of demonstrating that removal to federal court was proper. Because the plaintiff and another defendant in this case (the implanting surgeon) were from California, American Medical Systems could not meet its burden of proof to have the case removed to federal court.

The federal court also dismissed American Medical Systems reliance on the Eleventh Circuit’s so-called Tapscott doctrine, based on Tapscott v. MS Dealer Serv. Corp., 77 F.3d 1353, 1360 (11th Cir. 1996). The court found that the claims by the plaintiff against the California defendant and the vaginal mesh company had a real connection to each other. The plaintiff’s claims involved serious bodily injuries that she suffered as a result of a defendant doctor (and California citizen) surgically implanting American Medical Systems’ medical device known as the MiniArc® Sling System. American Medical Systems designed, manufactured, marketed and distributed the MiniArc® Sling System to ostensibly help women suffering with stress urinary incontinence. Accordingly, the federal court found that American Medical Systems failed to demonstrate that the parties in the case were completely diverse.

This is the first of six cases that American Medical Systems removed to federal court in February 2013. I’ll update the other five cases as the various federal district courts decide our requests to remand.

 

Testy Transvaginal Mesh Companies Lash Out At Injured California Patients

By Stewart R. Albertson on Posted in Drug & Device Litigation, Product Liability Litigation, Vaginal Mesh Litigation

I received notice yesterday of a third transvaginal mesh case in my office being removed to Federal Court by transvaginal mesh manufacturer American Medical Systems, Inc., under United States District Court case number 5:13-cv-00345-JGB-SP. This is the third transvaginal mesh company to remove one of my California state court cases to Federal Court this month. The other two vaginal mesh companies—C. R. Bard and Sofradim Production—removed a California vaginal mesh case to Federal Court on February 8, 2013 under United States District Court case number 2:13-cv-00672-SJO-CW.  I’m expecting more Federal Court removals in the coming weeks by these mesh companies.

These transvaginal mesh companies remove these California cases to Federal Court hoping they will not have to face California juries—who are likely to hold them liable for the harms to California patients. In most cases, once removed, the California patient’s case will be consolidated in the MDL (Multi-District Litigation) case in West Virginia where these patients have little or no control over how their case moves forward.

These cases can be transferred back to California State courts but the problem lies in the complexity required to have the injured patient’s case transferred back to California. And the vaginal mesh device companies know it; that’s why they remove these cases to Federal Court. I’ve received quite a few phone calls from plaintiff’s attorneys asking how to get these cases back to state court. It’s a procedural quagmire.

If a plaintiff’s attorney representing an injured California patient does nothing, the removed case will be transferred from the California Federal Court to the federal “MDL Court” (filed under Federal District Court Case No. MDL No. 2187) in West Virginia where it will be added to thousands of cases already filed against American Medical Systems. And once there, the injured patient’s case will not see the light of day.

Of course I’ll file motions in the Federal Court to have the cases returned to California State court where they belong. Once these cases come back to California, it’s my job to make sure California juries hear about the harms caused to California patients by these transvaginal mesh devices.

If you need help getting your case back to California, let me know and I’ll tell you how.

The best blog post I’ve read this year: By drug and device defense attorney Stephen McConnell

By Stewart R. Albertson on Posted in Drug & Device Litigation, Product Liability Litigation

I’m exhausted and in need of a pharmaceutical. I just finished my voyage through defense attorney Stephen McConnell’s blog post on 40 Accutane MDL court cases being dismissed. The journey started out fairly straightforward when I saw the title of the post that clued me in on the subject matter to be discussed—I naively presumed—40 Accutane MDL court cases being dismissed. But what followed was… well, here’s what followed:

Stephen’s erudite post addressed the following subjects:

  • Downton Abbey,
  • Catching up with Downton Abbey with a Betamax machine (a Betamax machine?)
  • Referring to some musical group called “The Beatles” (Who are The Beatles?),
  • Asking readers to try this stuff called vanilla ice cream,
  • Downton Abbey actors dying,
  • Breaking Bad offering relief from that cruel show Downton Abbey,
  • Drug dealing (presumably illegal, not the legal drug dealing that Stephen’s clients are involved with) and murder that does not toy with Stephen’s emotions like Downton Abbey,
  • Providing a link to “Breaking Abbey”,
  • Cursing out two dudes, Daniel J. Travanti and David Caruso.

And that was just the first paragraph. But the my journey was not complete as Stephen’s soliloquy continued:

  • Referring comparatively between a charming fictional lawyer and distinguished legal scholar Ronald Dworkin,
  • Referring to former United States Attorney General Edward Levi,
  • The Rule of Shelley’s Case,
  • The distinction between larceny by trick and obtaining property by false pretenses,
  • Some guys named Bentham, Rawls, and Dworkin,
  • Frustrated by Dworkin’s impenetrable prose in his book with such a straightforward title “Taking Rights Seriously” (Tell me about it),
  • Dworkin’s insistence on law’s moral dimension being undeniably refreshing,
  • Comparing Dworkin with Posner some Seventh Circuit Judge (I give that one a Hand),

And that is how the second paragraph ended. I grabbed a towel to wipe the sweat from my forehead and slammed two 5-hour ENERGYs back to back (I probably should have read the warning labels). I was not going to let this post beat me. I continued on to Stephen’s third paragraph repeating “I think I can, I think I can.”

  • Dworkin’s Wall Street Journal obituary,
  • Fish exposed to anti-anxiety drugs via industrial run-off or sewage becoming less social but braver,
  • Ichthyo-courage (okay, where’s my dictionary),
  • A pun using the word “hooked” (I presume for the “ichthyo” reference),
  • Stephen was now anxious,
  • How bits of news and pop culture would affect judges and jurors,
  • Stephen found at least one creature that a device rep did not attempt to lure in (hmmmm, not sure about that. Of course the device reps I deal with need over 20 hours of prep time for their depositions),

The third paragraph ended, and the fourth began… Nooooooooo.

  • Referring to Side Effects, The Constant Gardener (oh, oh, I know that one), and Love and Other Drugs,
  • Side Effects says bad things about drug marketing, doctors and patients.

And then Stephen got back to his title and discussed the 40 cases that are now gone out of the MDL. Whew.

I was finished. But my brain hurt. I quickly set up an appointment with my “learned intermediary” who prescribed me a pharmaceutical drug that was expressly and impliedly warranted to act differently, but maybe not better, than a placebo pill.

While writing out the prescription, my doctor did caution me that the manufacturer of this drug withheld the results of five out seven of its sponsored clinical trials. “You see,” my doctor said “these drug companies make doctors like me sign gag clauses that won’t let me tell you, or anyone else, about how bad the results were in those five trials that were withheld.”

That was good enough for me. Since I must rely on my “learned intermediary” I smiled and popped a pill, even if it did significantly increased my chance of a cardiac event (or even the dreaded dry mouth).

My Odyssey, much like that of Icarus, came to an end with the sun setting off my deck. I kicked myself and thought, if only I had not ignored my father’s instructions not to read that post.

California Law Allows Failure-To-Warn Strict Liability Claims Against Drug and Medical Device Manufacturers

By Stewart R. Albertson on Posted in Product Liability Litigation, Vaginal Mesh Litigation

California law allows failure-to-warn claims against drug and medical device companies based on strict liability. One of the defense attorneys I litigate against routinely argues with me that California law does not support a failure-to-warn cause of action based on strict liability for medical devices. That defense attorney’s firm, Reed Smith, represents American Medical Systems in the vaginal mesh litigation ongoing across the country–as well as other drug and medical device manufacturers. In response to that attorney’s argument I cracked open several California cases and found that California does indeed allow for strict liability claims for failure-to-warn cases.

Why does this defense attorney want me to believe California law does not support strict liability claims for failure-to-warn cases? Because juries will find his clients–drug and medical device companies–liable for their defective drugs and devices based on strict liability. Strict liability is a somewhat easier standard to prove than a general negligence failure-to-warn claim.

So what’s the difference between failure-to-warn claims brought on strict liability grounds versus the same claim brought under general negligence principles? Let’s see what California law has to say. The difference between (1) a failure to warn negligence claim, and (2) a failure to warn strict liability claim, is explained in Anderson v. Owens-Corning Fiberglas Crop.:

[F]ailure to warn in strict liability differs markedly from failure to warn in the negligence context. Negligence law in a failure-to-warn case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about. Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer’s conduct. The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Thus, in strict liability, as opposed to negligence, the reasonableness of the defendant’s failure to warn is immaterial.

Stated another way, a reasonably prudent manufacturer might reasonably decide that the risk of harm was such as not to require a warning as, for example, if the manufacturer’s own testing showed a result contrary to that of others in the scientific community. Such a manufacturer might escape liability under negligence principles. In contrast, under strict liability principles the manufacturer has no such leeway; the manufacturer is liable if it failed to give warning of dangers that were known to the scientific community at the time it manufactured or distributed the product. (Anderson v. Owen-Corning Fiberglas Crop. (1991) 53 Cal.3d at pp. 1002-1003.)

The California Supreme Court re-affirmed Anderson in Carlin v. Superior Court in 1996. In Carlin, a drug company asked the Supreme Court to reject the strict liability standard outlined in Anderson for cases involving drug companies where a failure-to-warn claim was made. The California Supreme Court found no sound basis for granting the drug companies request, holding that a patient harmed by a prescription drug can bring a strict liability claim for the drug company’s failure to warn about its dangerous drug.

I can already hear my defense attorney friend telling me that Anderson was an asbestos case and Carlin was a prescription drug case, so neither applies to a medical device case. But the California Supreme Court made sure to state that strict liability applies to manufacturers of all products, which includes medical device manufacturers.

As such, any claim made against a drug or medical device manufacturer should include a claim based on strict liability for failure to warn, which supported by Anderson and Carlin.

Defeat Drug and Medical Device Companies’ Motions for Summary Judgment Every Time in California

By Stewart R. Albertson on Posted in Bone Graft Litigation, Discovery, Infuse Litigation, Medtronic Litigation, Product Liability Litigation, Vaginal Mesh Litigation

Whether its vaginal mesh litigation, Infuse bone graft litigation, or Johnson & Johnson hip implant litigation you can always count on these medical device companies bringing one or more motions for summary judgment hoping to have an injured patient’s case thrown out of court before its heard by a jury.

But there’s good news for patients in California who are injured by these drug and medical device companies—these injured patients can defeat the drug and device companies’ motions for summary judgment every time based on failure to warn.

Before I show you how to defeat these motions for summary judgment, we first have to understand the theory these companies argue. And it’s simple. The medical device and drug companies attempt to hide behind the “learned intermediary doctrine” as a defense every time to support their motions for summary judgment.

The learned intermediary doctrine stands for the principle that manufacturers of prescription drugs and medical devices discharge their duty to warn about the drug’s or device’s risks by providing a warning to the prescribing doctor. In other words, a drug or device manufacturer is not required to warn the ultimate consumer—the patient—about their drug’s or device’s risks. (You can read my earlier post on why the learned intermediary doctrine is outdated.)

So, the drug or device companies motion for summary judgment will always contain a defense that the doctor was told about the risks of a drug or device and chose to use it anyway on the patient. As such, the theory goes, the patient cannot claim that he or she did not receive an adequate warning pertaining to the drug or medical device directly from the manufacturer.

But the learned intermediary doctrine is easily overcome in California at the initial complaint stage, or if required, by way of an amended complaint. The complaint needs some type of language as follows:

On information and belief, the drug or device company, has consistently underreported and withheld information about the propensity of its drug or device to fail and cause injury and complications, and has misrepresented the efficacy and safety of this product intending to mislead the public, ultimate consumers, and prescribing doctors.

Moreover, on information and belief, the drug or device company has intentionally underreported adverse events associated with its drug or device attempting to keep prescribing doctors from knowing the true risks associated with the drug or device.

As such, the drug or device company had a duty under state law to adequately warn prescribing doctors of the drug’s or device’s dangerous properties or of facts that make it likely to be dangerous.

And that’s it. Now, do discovery and you will find that the drug and device company was aware of risks (not on the warning label) associated with its drug or device that it chose not to give to doctors—the so-called learned intermediaries. Because the drug or device company chose not to provide an adequate warning to prescribing doctors, the doctor could not be “learned” about the true risks associated with the drug or device.

Voila! You just defeated the drug or device companies’ motion for summary judgment. Now your case goes in front of a jury—the drug or device companies’ greatest fear.

California Patients Face Life-Threatening Complications from Medtronic’s InFuse Bone Graft Medical Device

By Stewart R. Albertson on Posted in Bone Graft Litigation, Infuse Litigation, Medtronic Litigation, Product Liability Litigation

A recent U.S. Senate investigation report revealed that InFuse Bone Graft medical device maker Medtronic influenced peer-review articles in exchange for hundreds of millions of dollars paid to consulting doctors. You can review the U.S. Senate’s investigation report here.

Since the Senate’s investigation report InFuse Bone Graft lawsuits are on the rise in California. California patients have suffered life threating complications from Medtronic’s bone graft medical device.

Independent investigations, news organizations including the New York Times and Wall Street Journal, and the referenced Senate investigation report have raised allegations that Medtronic illegally promoted its Infuse Bone Graft medical device for off-label use by doctors.

The complications from the InFuse Bone Graft device include:

  • Difficulty breathing, swallowing or speaking
  • Compression of the airway
  • Respiratory depression
  • Male Sterility and retrograde ejaculation in male patients
  • Uncontrolled bone growth
  • Nerve damage
  • Chronic radiating pain in the legs or arms
  • Cancer

The life-threatening complications from the Infuse Bone Graft caused the FDA to issue a Public Health Notification in July 2008 entitled “FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion.” You can read the FDA’s 2008 Public Health Notification here.

Recently Medtronic attempted to rid itself of state lawsuits by injured patients. But the Ninth Circuit Court of Appeal said “no” to Medtronic’s immunity grab, finding that injured patients have a right to file a state-law action for Medtronic’s failure to warn the FDA about dangerous complications from its medical devices. That same rule applies to Medtronic’s InFuse Bone Graft medical device. You can read my analysis of the Ninth Circuits decision here.

Unless the U.S. Supreme Court decides to overturn the Ninth Circuit’s decision, which it appears it will not, Medtronic will be held responsible for the patients it injures with its medical devices—including the InFuse Bone Graft medical device.

 

Serious Complications Associated with Surgical Mesh used to Treat Pelvic Organ Prolapse and Stress Urinary Incontinence

By Stewart R. Albertson on Posted in Product Liability Litigation, Vaginal Mesh Litigation

In five short months it will be two years since the FDA issued its 2011 Safety Communication regarding serious complications associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse. You can review the FDA’s 2011 Safety Communication here. While the title of the Safety Communication expressly states “Pelvic Organ Prolapse”, the content of the warning refers to “Stress Urinary Incontinence” as well.

The 2011 Safety Communication refers to the FDA’s October 20, 2008 Public Health Notification on serious complications assocated with surgical mesh placed through the vagina to treat pelvic organ prolapse and stress urinary incontinence. You can review the FDA’s 2008 Public Health Notification here.

The FDA’s 2008 Public Health Notification

The 2008 Public Health Notification states the FDA received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to report pelvic organ prolapse (POP) and stress urinary incontinence (SUI). These mesh devices were generally placed transvaginally.

The most frequent complications from the vaginal mesh included: erosion, infection, pain, urinary problems, and recurrence of POP or SUI. There were also reports of bowel, bladder, and blood vessel perforation during surgical insertion. The reports also indicated vaginal scarring that led to a significant decrease in a patient’s quality of life, including painful sexual intercourse.

The FDA’s 2011 Safety Communication

The 2011 Safety Communication states that surgical mesh for transvaginal repair of POP is a continuing serious concern. Also, serious complications associated with surgical mesh for transvaginal repair of POP are not rare. The FDA continues stating that its not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh surgical repair, and mesh repair may expose patients to greater risk.

Two Year Statute of Limitations Defense?

It’s likely that the mesh companies view July 13, 2011–the date the 2011 Safety Communication was made–as the initial date starting a two-year statute of limitations period, meaning all injured patients have to file a lawsuit for damages pertaining to mesh used to surgically repair POP or SUI on or before July 13, 2013. It remains to be seen if the mesh companies are correct. I’m sure we’ll see the mesh companies raise the statute of limitations defense in every case filed after July 13, 2013.